Catalog Number

-

Brand Name

Hypure Oil Light 100mL

Version/Model Number

MOLH-100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MQL

Product Code Name

MEDIA, REPRODUCTIVE

Public Device Record Key

4b7beeab-cb41-4197-bb53-4a694d8f64f8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 08, 2016

Package DI Number

14582231460370

Quantity per Package

1

Contains DI Package

04582231460373

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-